(22 days)
The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm). The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.
Electronic Thermometer
The provided document is a 510(k) summary for the "Standard Thermometer" by Global Treasures Industrial, Inc. It details the product, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study results, acceptance criteria, or the specific information required to answer all the questions comprehensively.
Based on the available information, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. A 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria as would be found in a full performance report. It states: "The Standard Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity)." This describes characteristics but not acceptance criteria for a performance study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not present in the provided 510(k) summary. This type of information is typically relevant for studies involving subjective interpretations (like medical imaging), which is not directly applicable to a digital thermometer's performance testing where ground truth would be established by highly accurate reference measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This question is not applicable to a thermometer. MRMC studies are used for evaluating diagnostic devices that rely on human interpretation, often with AI assistance, which is not the function of a standard electronic thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided 510(k) summary. For a thermometer, "standalone performance" generally refers to the device's accuracy and precision as measured against a known standard, which would typically be part of a performance study, but the details of such a study are not included here. The summary focuses on comparing it to another thermometer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided 510(k) summary. For a thermometer, the "ground truth" would typically be established by a highly accurate, calibrated reference thermometer.
8. The sample size for the training set:
This information is not present in the provided 510(k) summary. This question is typically relevant for machine learning or AI-based devices, which a standard digital thermometer is not.
9. How the ground truth for the training set was established:
This information is not present in the provided 510(k) summary. As above, this question is typically relevant for machine learning or AI-based devices.
In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence. It lacks the detailed technical performance study information, acceptance criteria, and ground truth establishment methods that would be found in a comprehensive device performance report.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.